Senior Clinical Research Associate II

Responsibilities include but are not limited to:

• Monitoring independently different sites, including RBM.
• Participation in investigator meeting as necessary
• Ensuring the trial is conducted in accordance with the approved protocol ICH-GCP guidelines, SOPs etc
• Ensuring effective communication between investigational sites and internal/external stakeholders
• Working on project work and initiatives for process improvement as required

Requirements

Education and Experience:

• Degree in pharmacy, life science or related field
• 3 - 5 years' experience in a pharmaceutical, biotech or CRO company
• Independent clinical monitoring experience, at least 3 year
• Oncology trials experience - preferred
• Fluency in English, French and Dutch

Knowledge, Skills and Abilities:

• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of GCPs and applicable SOPs
• Management of regulatory and / or IEC questions
• Development and preparation of the local informed consent form
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Management of the delivery of study supplies
• Strong customer focus
• Effective interpersonal skills
• Strong attention to detail
• Effective organisational and time management skills
• Proven flexibility and adaptability
• Ability to work in a team or independently as required
• Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
• Good presentation skills